In the United States Court of Federal Claims
No. 09-300V
(Filed: December 19, 2014)
(Reissued: January 6, 2015)1
**********************
KIM and RICHARD CASTALDI,
Parents and next of kin to Vincent
Castaldi, a minor,
Petitioners,
Vaccine injury; Autism;
Hepatitis A vaccine;
v.
Timeliness; Onset of
symptoms.
SECRETARY OF THE
DEPARTMENT OF HEALTH AND
HUMAN SERVICES,
Respondent.
*********************
Andrew D. Downing, Phoenix, AZ for petitioners.
Darryl R. Wishard, United States Department of Justice, Civil Division,
Washington, DC, with whom was Stuart F. Delery, Assistant Attorney
General, Rupa Bhattacharyya, Director, Vincent J. Matanoski, Deputy
Director, Gabrielle M. Fielding, Assistant Director, for defendant.
OPINION
BRUGGINK, Judge
Currently before the court is petitioners’ motion for review of the
Special Master’s findings of fact pertaining to onset, filed on April 26, 2012,
1
In accord with the Rules of the Court of Federal Claims (“RCFC), App. B,
Rule 18(b), this opinion was initially filed under seal to afford the parties with
14 days to propose redactions. The parties did not propose any redactions.
Accordingly, the opinion is reissued publically in its original form save for
correction of two minor clerical errors.
and her subsequent decision for respondent of June 25, 2014, which held that
the petition was untimely and, in the alternative, that petitioners had not shown
causation. The matter is fully briefed, and oral argument was held on
December 2, 2014. Because we find no legal error or other irrationality in the
conclusion that the petition was untimely, we deny petitioners’ motion for
review.
BACKGROUND 2
On May 12, 2009, petitioners Kim and Richard Castaldi filed a petition
for compensation under the National Childhood Vaccine Injury Act, 42 U.S.C.
§ 300aa-1 to 300aa-34 (2012) (“Vaccine Act”), on behalf of their minor son,
Vincent. The petition alleges that Vincent had a severe adverse reaction to a
hepatitis A vaccine he received on May 8, 2006. Subsequent to filing, Vincent
was diagnosed with autism spectrum disorder, and petitioners now allege that
it was caused by the hepatitis vaccine. Respondent moved to dismiss the case
as untimely, arguing that the medical records demonstrated onset of symptoms
more than 36 months before the petition was filed. The case was stayed
pending the Federal Circuit’s decision in Cloer v. Secretary of Health &
Human Services, as it pertained to the issue of the Vaccine Act’s statute of
limitations. Cloer was decided en banc on August 5, 2011. 654 F.3d 1322
(Fed. Cir. 2011).3
The Special Master conducted a hearing on December 14, 2011. She
took testimony from fact and expert witnesses, along with documentary
evidence from experts. On April 26, 2012, the Special Master issued an Order
and Ruling on Facts Pertaining to Onset. In it, the Special Master delineated
2
The facts are drawn from the Special Master’s rulings dated April 26, 2012,
and July 29, 2014, and from the exhibits cited therein. Those opinions were
originally issued earlier but were released to the public on the dates indicated
above.
3
42 U.S.C. § 300aa-16(a)(2) imposes a 36-month time limit for filing a
petition after symptom onset. The Federal Circuit in Cloer held that, although
the Vaccine Act’s limitations period was not jurisdictional and could therefore
be tolled, at least theoretically, the test for when it begins running is an
objective one based on the first occurrence or manifestations of symptoms, not
on the date when the petitioners knew or should have known of the injury. 654
F.3d at 1337-39.
2
facts that are not in dispute about symptom onset, and made a number of
findings on disputed points relating to Vincent’s condition and the timing of
various symptoms. The Special Master also directed petitioners to provide
further records regarding Vincent’s daycare programs and especially any
applications for admission and evaluations regarding behavior and skills. She
also allowed the parties to file additional expert reports regarding “whether the
behaviors identified are recognized as symptoms of an autism spectrum
disorder by the relevant medical community.” Castaldi v. Sec’y of HHS, No.
09-300V, slip op. at 20 (Fed. Cl. Apr. 26, 2012). The parties were directed to
conform any additional expert opinions to the facts as found in the post-
hearing order. The parties were also afforded an opportunity to file briefs
regarding the Federal Circuit’s en banc decision in Cloer. The Special Master
did not rule on respondent’s motion to dismiss at that time.
Petitioners then filed a motion for review of the factual findings related
to onset. We denied that petition as not ripe for disposition because the
Special Master’s decision was preliminary and ruled on neither the motion to
dismiss nor on petitioners’ claim for compensation. Castaldi v. Sec’y of HHS,
No. 09-300V (Fed. Cl. July 12, 2012) (order denying motion for review as
unripe).
After another stay pending appeal of the decision in Cloer to the
Supreme Court, the parties submitted additional evidence and expert opinion.
Respondent submitted the report of Dr. Max Wiznitzer; petitioners elected not
to submit any supplemental reports. The Special Master issued a decision on
June 25, 2014, made public on July 29, 2014, which incorporated her earlier
findings and evaluated the additional information submitted by the parties.
She held that petitioners failed to establish the timeliness of their petition
because the weight of the evidence suggested that Vincent’s symptoms
manifested earlier than three years prior to the filing of the petition. Castaldi
v. Sec’y of HHS, No. 09-300V, 2014 WL 3749749, at *15 (Fed. Cl. June 25,
2014). She thus dismissed the petition as untimely. The Special Master also
held, in the alternative, that petitioners had not met their burden to prove
causation, specifically rejecting petitioners’ expert’s opinion as lacking any
causative theory. Id. at *16. We turn now to the specifics of the evidence and
the Special Master’s decision.
I. Medical Records
A review of the relevant medical records reflects the following facts.
Vincent was born on April 14, 2004. His condition as a newborn was recorded
3
as healthy, and contemporaneous medical records further report that he grew
and developed normally through his first year. He received normal childhood
vaccines during that year. He experienced several minor illnesses, none
unusual, but was not hospitalized during his first year.
His treating pediatrician, Dr. Pilar Escobar, noted appropriate growth
and development at his nine-month visit in January 2005. Dr. Escobar
recorded that Vincent was able to stand, cruise, and engage in vocal play. At
his 12-month visit, Vincent’s mother, Mrs. Castaldi, reported to Dr. Escobar
that Vincent had just begun walking that week and that he was imitating
sounds. Dr. Escobar recorded that his developmental progress was normal.
Vincent was suffering from the flu but was otherwise a healthy child at the
time of this visit.
At Vincent’s 15-month check-up in July 2005, Dr. Escobar’s records
reflect that Vincent was in good health and was very active. His motor skills
were satisfactory, and he was recorded as having a “few word” vocabulary and
chattering frequently. Id. at *4. Similar results were noted during Vincent’s
18-month visit. Mrs. Castaldi reported and Dr. Escobar noted that Vincent had
begun using small phrases in speech. Vincent was administered the influenza
vaccine during this visit.
Vincent visited Dr. Escobar several times throughout the next three
months for a viral malady, influenza, and bronchitis. He had a 101 degree
temperature preceding a January 27, 2006 visit, and he tested positive for
influenza. After recovering from the flu, Vincent did not visit the doctor again
for several months.
Vincent’s two-year doctor’s visit took place on May 8, 2006.4 Dr.
Escobar’s notes reflect that Vincent babbled but was overall quieter than his
sister had been at that age. Vincent was recorded as having a good appetite.
Dr. Escobar also noted concerns from Mrs. Castaldi regarding Vincent’s vision
because he frequently bumped into things, especially on his left side. Mrs.
Castaldi thought that he had trouble focusing on close objects. Otherwise,
Vincent was recorded by Dr. Escobar to be in good health and to have a “few
word vocabulary,” talking in short sentences. Id. at *5. She also recorded that
Vincent was very active, inquisitive, and had explored the room during the
4
Vincent’s records also show a cancelled optometry appointment in March
2006.
4
visit. Dr. Escobar referred Vincent to an ophthalmic evaluation. Vincent was
also given the allegedly causal hepatitis vaccine at the conclusion of the visit.
Vincent and his mother visited an ophthalmologist two weeks later on
May 23, 2006. Dr. Brown, the ophthalmologist, recorded that Vincent cried
throughout the examination. He also noted that, in addition to vision
problems, Mrs. Castaldi, who is a speech pathologist, stated concerns
regarding Vincent’s speech. Dr. Brown concluded that Vincent was
farsighted, believed that he had a “mixed developmental disorder,” and
advised consultation with a neurologist. Id.
Mrs. Castaldi discussed the results of Dr. Brown’s evaluation with Dr.
Escobar on June 8, 2006. Dr. Escobar’s notes from that visit reflect that he
and Vincent’s mother discussed both Vincent’s vision difficulties (poor
peripheral vision and bumping into close objects) and possible speech delay.
The notes further record that Vincent played well with his older sister, but did
not have a lot of contact with other children. Dr. Escobar also noted that
Vincent “vocalizes but has limited verbalization” and that he reacts to sound
by turning to investigate it. Pet’rs’ Ex. 11 at 150. Based on her observation
at the time, in Dr. Escobar’s opinion, Vincent’s “motor tone and activity
[were] appropriate for [his] age.” Id.
Dr. Escobar saw Vincent again on August 22, 2006, when Mrs. Castaldi
brought him in with an apparent bout of stomach flu. The notes from that visit
reflect that Mrs. Castaldi was concerned that Vincent’s appetite had regressed
and that he was shaky upon waking in the mornings. Mrs. Castaldi was also
concerned that Vincent was clumsier in general and ran into objects in his left
field of vision. She further expressed concern that his oral communication had
regressed, specifically that, instead of speaking in words and short sentences,
he mostly jabbered. Mrs. Castaldi thought that Vincent was experiencing
abnormal separation anxiety from her and that he needed to have a toy with
him at all times. Mrs. Castaldi traced these changes back to “the spring.” Id.
at 152. Dr. Escobar’s physical examination showed no particular problems,
and she recorded that Vincent’s “motor tone” was “satisfactory.” Id. Dr.
Escobar was concerned with Vincent’s speech and activity regression. Her
treatment plan included a future cranial MRI and possible referral for a
neurological evaluation. Notes from a follow-up visit a week later show that
an MRI and a further pediatric ophthalmic evaluation had been scheduled.
Dr. Escobar saw Vincent again on September 22, 2006. His mother
reported an episode that occurred on September 18 in which Vincent became
5
very stiff on his way to preschool, and Mrs. Castaldi thought that Vincent’s
movements had been “jerkier” ever since. Id. at 156. The notes from that visit
also reflect that Mrs. Castaldi relayed that Vincent would not sit still at school
and did not interact with other children. Dr. Escobar did not believe that
Vincent had suffered a seizure but did recommend that Vincent receive an
EEG test with Dr. Marc Hille. She also recorded that Vincent’s MRI had not
shown anything abnormal.5 The notes also state that a special needs program,
Sooner Start, was evaluating Vincent for eligibility to receive care.
Vincent’s first Sooner Start evaluation took place at home on July 31,
2006. Records from that evaluation reflect that Dr. Escobar thought Vincent’s
motor skills were appropriate for his age but that other developmental skills
might be delayed. The notes also recorded that Vincent was at a preschool
twice a week, the one referred to by Dr. Escobar at which Vincent did not
interact with his classmates. As part of the Sooner Start continuing evaluation,
Mrs. Castaldi filled out two questionnaires regarding Vincent. One was for his
condition at 27 months and the other for his condition at 30 months of age.
Although she reported that his gross motor skills were adequate, he was unable
to follow simple instructions such as “close the door” or “take my hand.”
Pet’rs’ Ex. 13 at 482. Additionally, Mrs. Castaldi indicated that Vincent could
not point to his body parts on command or identify pictures of simple objects.
She also reported that he had, since the late Spring, stopped using simple
phrases such as “me drink.” Id. She dated the beginning of his regression to
the “late spring.” Id. at 485. The 30-month questionnaire further revealed that
Vincent was now more clingy than before, indicating that Vincent had been
fine to attend a Sunday morning children’s program at church up until “late
spring.” Id. at 489. He did not like to be cuddled, did not greet familiar adults,
and did not like stories. Although he appeared happy, he neither liked to play
with others nor followed directions.
The evaluator also noted that Vincent appeared interested in toys and
had adequate motor skills. Although Vincent vocalized, he did not use words
during the initial home evaluation. The notes from that visit reflect that
Vincent had been imitating words and using two-word phrases formerly but
5
Petitioners did take Vincent to Dr. Hille, and the notes from that visit on
November 8, 2006, reflect much the same as those of Dr. Escobar’s: Vincent
had been progressing normally until age two. Dr. Hille recommended an EEG
to rule out an epileptic cause of developmental delays and noted the possibility
of autism. See Pet’rs’ Ex. 7 at 34-35.
6
that “all stopped in the late spring” around the time that Vincent had the flu.
Id. at 593. Those records also show a handwritten note that Vincent had
suffered from the flu in February and that he had “lost a lot of words in
March.” Id. at 598. Vincent was referred to an occupational therapy
evaluation on September 14, 2006, and a plan to progress Vincent’s self-care
skills was outlined.
Dr. Escobar referred Vincent to a developmental pediatrician, Dr.
Laurie Kukas. Dr. Kukas evaluated Vincent for the first time on November 4,
2006. Her notes from that visit reflect that Vincent was progressing normally
“until shortly after his 2nd birthday.” Pet’rs’ Ex. 11 at 257. Vincent was
responding to his mother’s direction and pointing at things when he was 18
months old, according to Dr. Kukas’ notes, and Mrs. Castaldi observed a 30
word vocabulary. “Approximately 2 months prior to his initial evaluation, he
regressed to jargon.” Id. The notes from that visit go on to record that the
petitioners were concerned with a possible autistic disorder, but Dr. Kukas
noted that “his regressions are later than typically reported with these
disorders.” Id. at 258. The notes also stated that Vincent had been
overwhelmed at preschool and had been pulled out of that program in
September 2006. Petitioners also reported to Dr. Kukas episodes of blank
staring beginning in May or June of 2006. Dr. Kukas diagnosed “global
developmental delays . . . with history of normal milestones until 2nd birthday
followed by regression especially in speech/language, social, and adaptive
areas.” Id. at 259. She suspected autistic spectrum disorder (“ASD”) but
wanted to address the possibility of seizures before a formal diagnosis of ASD.
Vincent was evaluated at Cook Children’s Medical Center for global
developmental disorders on February 19, 2007, when he was formally
diagnosed with ASD. Vincent was later referred to a child neurologist, Dr.
Harley Morgan, and another pediatrician Dr. Kathleen Koljack. The records
of neither of these doctors were discussed by the Special Master in her
findings of fact and subsequent opinion except as noted below.
II. Hearing Testimony
At the hearing in December 2011, the Special Master heard testimony
from Dr. Escobar and from Mrs. Castaldi. We briefly summarize their
testimony below.
A. Dr. Escobar’s Testimony
7
For the most part, Dr. Escobar’s testimony traces her notes as outlined
above. She testified that she thought petitioners to be responsible parents, and
that being the case, she would expect the Castaldis to have brought Vincent in
for an examination if he was showing signs of a neurological condition. Dr.
Escobar testified that she did not observe any signs of neurological disorder
prior to Vincent’s visit on June 8, 2006–a month after the vaccine was
administered. She also testified that most of the information in her notes
concerning Vincent’s speech and behavioral development were from Mrs.
Castaldi’s oral reporting and not her own examination. See, e.g., Tr. 22, 34.
The Special Master asked Dr. Escobar whether she used any checklists,
such as the Denver Developmental Inventory or similar tools in assessing
Vincent’s development. Dr. Escobar answered that she used them
“informally” by asking questions typical of “those types of screens” but that
she did not use a checklist or any sort of pass/fail test. Tr. 32-33. The Special
Master also asked Dr. Escobar to quantify her use of the term “few words,”
which appeared in her notes from the July 2005 and May 2006 examinations.
She was unable to do so. She did explain that she meant “a few words that
could be clearly understood” as reported by Mrs. Castaldi, who was known to
Dr. Escobar as a speech therapist. Tr. 34. The court followed up by asking
what would have triggered Dr. Escobar to have been concerned about the
child’s vocabulary. Dr. Escobar indicated that, at two years of age, if the child
was unable to say simple words like “mama” or ‘dada,” she would have been
concerned. Tr. 35. She was unable to recall what the Denver Developmental
Inventory regarded as a normal vocabulary for a two-year old child.
Dr. Escobar further testified that she found Mrs. Castaldi to be a reliable
observer and reporter of Vincent’s progress. See Tr. 36. Dr. Escobar would
therefore expect Mrs. Castaldi to have given “fairly consistent accounts over
time of the same event.” Tr. 39.
B. Mrs. Castaldi’s Testimony
Mrs. Castaldi was, during the period in question, Director of Special
Services for Sapulpa Public Schools. She had previously been employed as
a speech and language pathologist. She holds a Master of Science in
communication sciences and disorders and a Master of Education in school
counseling.
Based on her professional experience, Mrs. Castaldi believes that
Vincent’s speech development at 15 months was age appropriate. She testified
8
that Vincent recovered from the flu about a week after the January 2006 visit
to Dr. Escobar. She was asked by her counsel whether she observed any
speech or vocabulary problems directly after the flu in January 2006. She
answered in the negative. See Tr. 50. She further testified that she observed
nothing out of the ordinary with Vincent’s health or speech development
between that visit and the May 8, 2006 two-year check up.
Concerning the records from the May 8, 2006 visit, Mrs. Castaldi was
asked to clarify Vincent’s vocabulary level because the report from that visit
indicated that he had a “few word” vocabulary and “babble[d]” but also stated
that “he like[d] to talk in sentences.” Tr. 52. At the hearing, she testified that
Vincent had around a 500 word vocabulary and was “speaking in at least
three- to four-word sentences at that point, sometimes longer if the occasion
arose.” Tr. 53. As an example, if he wanted a drink, she recalled that he
would say “I want juice” or “I want a drink.” Id. As a speech pathologist, she
saw nothing wrong with his development as of May 8, 2006.
Mrs. Castaldi went on to testify that she began to be concerned
regarding Vincent’s speech about a week before Vincent’s ophthalmology
exam on May 23, 2006. She relayed a specific incident that had happened
between those two examinations. On May 19, 2006, she took Vincent with her
to work at the school, as she did frequently. She recalled Vincent being very
fussy and upset that day when he was with her at work. What caused Mrs.
Castaldi to take particular note, however, was that, when she brought Vincent
to her office, he did not react positively to a colorful poster on the wall that
displayed the alphabet. She testified that normally he would stop at that poster
and say some letters, pointing at the poster. She stated that, at that point,
Vincent knew his ABCs. Tr. 59. On May 19, 2006, however, Vincent “got
really upset and started crying.” Id. This was, in her recollection, the first
time that she was concerned about Vincent’s development because it was
different from how he acted in the past, and thus “it really caught [her]
attention.” Id.
On cross-examination, counsel for the government asked Mrs. Castaldi
if she could recall specific instances prior to May 19, 2006, when Vincent had
pointed at the alphabet poster and verbally repeated some of the letters. She
answered: “Not a specific date. No.” Tr. 80. Counsel then asked for a general
time, such as a month. She answered: “I really can’t specifically. I just
remember at least a couple of times, him coming up there and doing that ABC
poster, and we were working a lot with my daughter on her ABCs at that
point.” Id. She was then asked to give a general time when Vincent began to
9
say his ABCs. Mrs. Castaldi: “I would say probably shortly before his second
birthday, he could at least name them.” Tr. 80-81. She testified that Vincent
picked up the ABCs from observing Mrs. Castaldi working with her then-four-
year old daughter, who had experienced some developmental delays as well.
We note at this point the affidavit testimony of her husband, Richard
Castaldi. He stated in his declaration of November 28, 2011, that Vincent had
been, prior to May 8, 2006, developing normally. “He was singing typical
songs (like the alphabet) and was starting to say his ABCs. Pet’rs’ Ex. 17 at
700.
Mrs. Castaldi was asked to describe Vincent’s speech regression after
May 2006. She testified that it started slowly: he regressed from sentences,
such as asking for things, to labeling objects. The regression continued to a
general decline in his total vocabulary, eventually all the way back to “babble,
jargon, and just not understandable words.” Tr. 62. She was asked about the
statements in Vincent’s medical and school records that might indicate onset
of speech regression prior to the vaccine administration. She testified that she
may have stated that problems began after his struggle with the flu, but that,
in reality, the symptoms did not begin within 30 days of the doctor visit in
January 2006. She was also asked if she had told the Sooner Start evaluator
that Vincent’s problems began after his flu illness in February 2006 and that
he had “lost a lot of words in March.” See Tr. 63 (referencing the Sooner Start
evaluation in July 2006). She answered that she might have said that but that
Vincent had not had the flu in February. See Tr. 63-64. She explained that she
did not have Vincent’s medical records in front of her at the Sooner Start home
evaluation and that the purpose of that evaluation was not to pinpoint precisely
when things happened in his medical history. Tr. 65. She further stated that
this was generally the case with all of Vincent’s medical records. Exact timing
was not important.6 She did agree with respondent’s counsel, on cross-
examination, however, that accuracy in relaying symptom history is important
as a speech pathologist. See Tr. 86.
Mrs. Castaldi also testified regarding the vision problems that prompted
the referral to Dr. Brown. She recalled a specific event prior to the May 8 visit
6
Mrs. Castaldi also noted a further inaccuracy in the Sooner Start evaluation
record, in which it is stated that Vincent’s regression began after a bout with
the flu in the Spring of 2006. See Tr. 65-66. She stated that the regression did
begin then, May 2006, but Vincent did not have the flu during this period.
10
to Dr. Escobar when Vincent ran into a kitchen drawer that had been pulled
out. Mrs. Castaldi testified that this was one particular event that she took note
of and which prompted her to raise these concerns with Dr. Escobar. She also
testified that her experience with her daughter–presumably vision
problems–was also a factor in her concerns relayed to Dr. Escobar, mainly
because she had missed signs of problems in her daughter. She was asked by
her counsel whether she would have characterized Vincent’s movements at the
time as “stumbling around, running into walls and things like that” or even as
“drunk.” She replied “no, not at all.” Tr. 55.
III. Expert Opinion
The parties each presented the report of one expert. Petitioners
presented the opinions of Dr. Hastings, who holds a Ph.D. in anatomy and a
degree in osteopathic medicine. He is board certified in internal medicine. His
publications center on anatomy, hyperlipidemia, and cardiac medicine.
Respondent presented the opinion of Dr. Max Wiznitzer, who specializes in
treating childhood autism. He is board certified in pediatrics, psychiatry, and
neurology. He teaches and practices regularly in the field of pediatrics and
neurology. He has published numerous articles and book chapters on autism,
including diagnosing it. We briefly summarize their opinions below.
A. Dr. Hastings’ Opinion
Dr. Hastings’ report was tendered prior to the Special Master’s first fact
findings and was not updated after that decision. Dr. Hastings concluded that
Vincent’s ASD symptoms began after May 8, 2006, the date of the vaccine at
issue. He placed particular importance on Dr. Escobar’s notes from the May
8 visit, which he opined eliminate the notion that a January 2006 viral
infection (influenza or bronchitis) was causative of the symptoms.7 See Pet’rs’
Ex. 15 at 693. The report states that Dr. Escobar’s records from the May 8
examination confirm “the absence of . . . Autism or Autism like symptoms
predating May 8, 2006.” Id. After reviewing Dr. Escobar’s records as a
whole, he concluded that they establish “unequivocally . . . a normal
developmental child with normal speech patterns, talking in sentence[s],
7
Earlier in this litigation, the possibility that encephalitis (viral infection of the
brain) caused the onset of ASD was explored by the parties. In addition to
pinpointing onset, Dr. Hastings was tasked with determining whether that was
a likely cause.
11
awake, active, alert, and inquisitive and without any of the clinical
manifestations of Autism” prior to May 8, 2006. Id. His report goes on to
state that Vincent began to exhibit “outwardly noticeable adversities” within
eight days of the May 8 visit.8 Id. at 677.
B. Dr. Wiznitzer’s Opinion
Respondent filed Dr. Wiznitzer’s opinion after the initial factual
findings of April 26, 2012. He did not disagree with any of them. He
concluded, after reviewing all relevant medical records and the hearing
testimony, that Vincent’s regression began earlier than May 8, 2006, and
specifically that his speech regression began in the March-April 2006 time
period. Resp.’s Ex. F at 7. He found that the onset of other symptoms in
adaptive, social, and cognitive skills occurred later. Although the records
reflected a history of three to four word sentences in May 2006, he concluded
these were probably “echolalic in nature and an early manifestation of ASD.” 9
Id.
Dr. Wiznitzer acknowledged the diagnosis of motor incoordination in
November 2006, but stated that the earlier history of clumsiness and running
into things “with onset prior to 5/8/06 that was interpreted as being a visual
problem but, more likely than not, represented an early manifestation of his
motor incoordination.” Id. This further buttressed his opinion regarding the
earlier onset of ASD symptoms.
His report reflects that approximately 80 percent of parents of autistic
children notice symptoms within the first 24 months, especially speech and
language development impairment. Id. at 8. This he found to be consistent
with his view that Vincent’s speech delay predated his May 8, 2006 visit with
Dr. Escobar. He stated that the speech regression was the “initial
manifestation of his regressive ASD.” Id.
8
It is not clear what event from the medical records Dr. Hastings identified as
the beginning of the symptoms, but we note, as the Special Master did, that
eight days later was May 16, three days before Mrs. Castaldi relayed noticing
the beginning of Vincent’s speech regression. Castaldi, 2014 WL 3749749,
at *14.
9
Echolalia is characterized as the rapid repetition of words spoken by another
person.
12
IV. The Special Master’s Decision
The Special Master, after considering all of the evidence, dismissed the
petition as untimely, finding that Vincent’s symptoms of autism, speech
regression and motor skill deficit, began prior to May 12, 2006, which was 36
months prior to the filing of the petition. Castaldi, 2014 WL 3749749, at *15.
After reviewing all of the medical records and comparing them to Mrs.
Castaldi’s testimony, the Special Master did not find “sufficient indicia of
reliability in the testimony of Mrs. Castaldi to credit her testimony over the
evidence found in the contemporaneous records.” Id. at *10. She found Mrs.
Castaldi’s testimony to be inconsistent with the medical records and her
statements to the treating and evaluating physicians at the time of the events.
Specifically, Mrs. Castaldi’s testimony at the hearing that Vincent had a 500
word vocabulary on May 8, 2006, was particularly troubling to the Special
Master. She found that Mrs. Castaldi inflated Vincent’s vocabulary over time
and that this was an indicia of a lack of credibility as to that point. Id. Also
rejected by the Special Master was Mrs. Castaldi’s testimony regarding the
May 19, 2006 incident at her office because no mention of this episode was
found in any of the contemporaneous medical records. The first mention of
Vincent’s reaction to the alphabet picture appeared in a May 2011 affidavit of
Mrs. Castaldi. See id. at *12.
In assessing the medical records, the Special Master found Dr.
Escobar’s notes to be based primarily upon the recollection and retelling of
Mrs. Castaldi, and thus they could not be credited alone as establishing onset
after May 8, 2006. She also found internal inconsistencies in Dr. Escobar’s
notes which cast further doubt on their reliability as far as establishing a time
of onset, particularly the notes from the May 8, 2006 examination wherein
Vincent was described as talking in short sentences in one spot and babbling
with a few word vocabulary in another. See id. at *11.
More compelling as to actual onset for the Special Master were the
records from the Sooner Start evaluations and subsequent doctor examinations
in the fall of 2006 and following. She reasoned that “one would expect parents
to be as accurate as possible when conveying history about their child during
developmental evaluation or initial consultation by a specialist.” Id. The
Special Master found particularly telling the notation in the Sooner Start
records that Vincent “lost a lot of words in March,” and in Dr. Kukas’ notes
of November 4, 2006, that “developmental milestones were progressing
13
normally until shortly after his 2nd birthday.” Pet’rs’ Ex. 13 at 598; Pet’rs’
Ex. 11 at 257. She also noted the records of Dr. Hille from November 8, 2006,
which reflect that “normal speech and language development until just after
his second birthday,” as well as the records of Dr. Harley Morgan from the
April 30, 2007 initial consultation that Mrs. Castaldi did not notice language
problems until “around 2 years of age.” Pet’rs’ Ex. 7 at 34; Pet’rs’ Ex. 8 at 52.
Also important to the Special Master was the July 30, 2007 visit to Dr. Koljack
where she recorded that Vincent was “normal until shortly before second
birthday.” Pet’rs’ Ex. 10 at 103. These statements, taken in total, persuaded
the Special Master that the likely onset date of Vincent’s symptoms was more
than three years prior to filing of the petition.
Regarding the expert opinions, the Special Master found Dr. Wiznitzer
to be more qualified due to his experience with treating and diagnosing
childhood autism disorders. She thus placed greater weight and reliance on his
report. Relying on that report, the Special Master concluded that Vincent’s
speech regression began prior to May 8, 2006, and that his reported vision
problems also reflected early symptoms of autism. She thus ultimately
concluded that the petition was filed too late, not within 36 months of the onset
of symptoms, and dismissed it. Castaldi, 2014 WL 3749749, at *15; see also
2012 Slip. Op. at 17-18. In her July 2014 opinion, the Special Master also
addressed petitioners’ theory of causation and rejected it as insufficient and
unsupported by sufficient evidence, noting particularly that Dr. Hastings’
report, although naming the hepatitis vaccine as causal, was devoid of any
explanation of a biological mechanism whereby the vaccine caused the onset
of ASD. Castaldi, 2014 WL 3749749, at *16. The Special Master noted that
she had given petitioners several opportunities to supplement their evidence
of causation. Without further evidence, the Special Master concluded that
petitioners had not established causation and thus were not entitled to
compensation. Id.
DISCUSSION
We review decisions of Special Masters under the highly deferential
abuse of discretion standard. RCFC App. B, Rule 27(b). The Vaccine Act
mandates that the findings of fact below may be reversed only if they are
“arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law.” 42 U.S.C. § 300aa-12(e)(2)(B). Legal conclusions, however, are
reviewed without deference. Munn v. Sec’y of HHS, 970 F.2d 863, 870 n.10
(Fed. Cir. 1992). On review, we must not “reweigh the factual evidence . . .
or examine the probative value of the evidence or the credibility of the
14
witness” because those “are all matters within the purview of the fact finder.”
Porter v. Sec’y of HHS, 663 F.3d 1242, 1249 (Fed. Cir. 2011).
Petitions for compensation under the Vaccine Act must be filed within
“36 months after the date of the occurrence of the first symptom or
manifestation of onset or of the significant aggravation of such injury.” 42
U.S.C. § 300aa-16(a)(2) (2012). This is “the first event objectively
recognizable as a sign of a vaccine injury by the medical profession at large.”
Markovich v. Sec’y of HHS, 477 F.3d 1353, 1360 (Fed. Cir. 2007). This is an
objective test based on symptoms that occurred and not on when the
petitioners or petitioners’ physicians diagnosed them. See Cloer, 654 F.3d at
1338-39.
Petitioners take issue with five aspects of the Special Master’s findings
and opinion: 1) failure to accord appropriate weight to the records and
testimony of Dr. Escobar as the treating physician; 2) error in giving greater
weight to later records as opposed to the contemporaneous records of Dr.
Escobar; 3) failure to understand the difference between a 500 word total
vocabulary and a 30 word set of commonly used words or phrases; 4) error in
rejection of Mrs. Castaldi’s testimony regarding the events of May 19, 2006;
5) error in affording too little weight to Dr. Hastings’ report.
Respondent argues that the Special Master’s earlier factual findings and
later opinion, taken together, make clear that she considered the record as a
whole, missing nothing, and appropriately weighed the evidence presented.
That the Special Master weighed certain evidence more favorably for
respondent is well within her discretion as the finder of fact, according to
respondent, and, because the record indicates onset of symptoms prior to May
12, 2006, the dismissal was proper. We agree.
We begin with petitioners’ final three exceptions. As to the distinction
petitioners argue regarding the difference between a 500-word total vocabulary
and some smaller subset of frequently used words, it is too late now to raise
that as an explanation for Mrs. Castaldi’s testimony. Petitioners argue that the
Special Master should have asked for further clarification rather than
“ambush” petitioners in her opinion by using it as a reason to discredit Mrs.
Castaldi’s testimony as a whole. We disagree. Petitioners’ counsel had every
opportunity on direct examination or redirect to ask Mrs. Castaldi to explain
her testimony regarding Vincent’s alleged 500-word vocabulary. Hearing no
further explanation, it was neither arbitrary nor capricious for the Special
Master to have taken note of the apparent discrepancy between that testimony
15
and the bulk of the medical records in this case. Nor was it irrational to
conclude that Mrs. Castaldi’s recollection could not be relied on, given the
wide variance between the sources, especially the records of Dr. Escobar,
which were based largely on Mrs. Castaldi’s recollection at the time of the
events.
As to the events of May 19, 2006, we are not in a position to second
guess the Special Master’s consideration of that piece of evidence in contrast
to the rest of the evidence in the case. She rejected Mrs. Castaldi’s testimony
in 2009 and 2012 regarding this event because the contemporaneous records
did not include any mention of it, and because there were other statements
indicating onset prior to that alleged event. We cannot say that this was
arbitrary or capricious.
The Special Master’s weighing of Dr. Hastings’ report is likewise not
irrational. The Vaccine Act tasks the Office of Special Masters with
considering voluminous medical records and after-the-fact expert reports. It
is precisely the role of the Special Master to sort between them and decide
which are the most persuasive. Petitioners’ argument that, as an internist, Dr.
Hastings is particularly well-suited to make a determination of causation and
onset is one best made below. The Special Master reached a different
conclusion. Petitioners have not identified a legal error in that conclusion, and
we are not in any position to substitute our judgment for that of the finder of
fact.
We also cannot say that it was reversible error for the Special Master
to assign relatively less weight to the testimony and notes of Dr. Escobar,
compared with later medical records. The Special Master recognized that
normally treating physicians are in a better position to assess and record the
medically relevant facts and diagnosis. See Andreu v. Sec’y of HHS, 569 F.3d
1367 (Fed. Cir. 2009). The Special Master considered Dr. Escobar’s records
and testimony as a part of the record as a whole. The fact that her records
were largely based on Mrs. Castaldi’s recollection rather than Dr. Escobar’s
own observations was of significance in the Special Master’s calculus. Her
conclusion that Mrs. Castaldi’s testimony lacked credibility and resulted from
faulty recall were relevant considerations in her weighing of Dr. Escobar’s
notes versus later statements in the medical records which reflected earlier
onset of symptoms. The fact that a reasonable finder of fact might have come
to a different conclusion does not establish legal error. See Hodges v. Sec’y of
HHS, 9 F.3d 958, 961 (Fed. Cir. 1993).
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We recognize that the records from Sooner Start and those of Doctors
Hille, Kukak, Morgan, and Koljack, cited by the Special Master as probative,
are not independently determinative of the date of onset. They, like the
records of Dr. Escobar, are based on the recollection of Mrs. Castaldi. The
Special Master, however, considered the record as a whole and was assisted
by expert opinion based also on that record. Dr. Wiznitzer came to the
conclusion that the evidence showed an earlier onset, and buttressed the
statements regarding loss of vocabulary in March or April of 2006 with his
independent view that Vincent’s vision problems predating the May 8, 2006
visit with Dr. Escobar actually represented a lack of motor skill indicative of
ASD. We note also the records of the visit with Dr. Koljack reflect problems
developing before his second birthday. This represents a reasonable basis in
the record on which the Special Master could reach the conclusion that she did.
See Lampe v. Sec’y of HHS, 219 F.3d 1357, 1360 (Fed. Cir. 2000) (stating that
a special master’s decision should be upheld if he or she considered all of the
evidence and provided a rational basis for the conclusion). It is inherent in the
vaccine program that such determinations be afforded great deference; we are
not tasked with a new weighing of the evidence but rather a review for
irrationality or other legal error. See Porter v. Sec’y of HHS, 663 F.3d 1242,
1249 (Fed. Cir. 2011). Petitioners have not presented a basis for finding such
in the Special Master’s decisions.
CONCLUSION
Because the opinion of June 25, 2014, and factual findings of April 26,
2012, with respect to timeliness10 were not arbitrary, capricious, or otherwise
not in accordance with the law, we must affirm them. Accordingly,
petitioners’ motion for review is denied. The Clerk of Court is directed to
enter judgment for respondent dismissing the petition.
s/ Eric G. Bruggink
ERIC G. BRUGGINK
Judge
10
It is unnecessary, therefore, to address the Special Master’s ruling as to
causation.
17